Trials / Completed
CompletedNCT03336645
Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan
A Phase 3, Multicenter, Open-label Study to Determine the Efficacy, Safety, and Pharmacokinetics of Buccally Administered MHOS/SHP615 in Pediatric Patients With Status Epilepticus (Convulsive) in the Hospital or Emergency Room
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 3 Months – 216 Months
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy, safety and pharmacokinetics of MHOS/SHP615 administered buccally in children with status epilepticus (convulsive) in a healthcare setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHP615 | SHP615 oromucosal solution will be administered as a single age-specific dose (2.5, 5, 7.5 and 10 mg). |
Timeline
- Start date
- 2017-10-23
- Primary completion
- 2019-08-19
- Completion
- 2019-08-19
- First posted
- 2017-11-08
- Last updated
- 2020-07-31
- Results posted
- 2020-07-31
Locations
23 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03336645. Inclusion in this directory is not an endorsement.